Sanofi’s multiple sclerosis drug flunks Phase 3 trial, faces another PDUFA delay
Sanofi reported that its BTK inhibitor which it said has blockbuster potential in multiple sclerosis hit setbacks in two different forms of the disease. The French drugmaker said tolebrutinib failed a ...
View ArticleWestern genetic medicine makers turn to Chinese investigator-initiated trials
Earlier this year, the Belgian cell therapy startup EsoBiotec had only 12 employees and had raised €22 million to develop a cutting-edge infusion that turns a patient's immune cells into destroyers of...
View ArticleAI biotech Chai Discovery raises $130M Series B at $1.3B valuation
Chai Discovery has closed a $130 million Series B at a $1.3 billion valuation, continuing a furious fundraising pace since being founded by a quartet of ambitious young brainiacs in 2024. ...
View ArticleSanofi returns to Dren Bio for another B cell depletion therapy at $100M upfront
For the second time this year, Sanofi is buying into the B cell depletion work at Dren Bio. The French pharma giant will pay $100 million upfront and up to ...
View ArticleImmunome's rare tumor drug passes Phase 3 test, could challenge Merck KGaA
Immunome’s rare tumor drug succeeded in a Phase 3 study, setting the company up for an FDA submission by the end of next June. Researchers said Monday that the drug, called ...
View ArticleAreteia Therapeutics to wind down after terminating Phase 3 asthma studies
Areteia Therapeutics, one of the biotech industry's biggest recent startup bets in respiratory illness, has decided to wind down, according to a source familiar with the decision. The company's top...
View ArticleKyverna to take autoimmune CAR-T to FDA after success in stiff person...
Kyverna Therapeutics' CAR-T therapy succeeded in a key study in stiff person syndrome, a rare autoimmune disorder that leads to painful muscle spasms and stiffness. The California biotech said Monday...
View ArticleInnoCare says Zenas-partnered drug succeeds in China study in form of lupus
InnoCare Pharma’s experimental oral BTK inhibitor, called orelabrutinib, succeeded in a mid-stage trial in systemic lupus erythematosus (SLE), the Chinese biotech said Sunday. After nearly a year’s...
View ArticlePalvella unwraps Phase 2 data for rapamycin gel in rare skin disease
Palvella Therapeutics said its drug candidate for a rare skin disease that affects children has yielded positive results in a mid-stage trial. The biotech’s gel treatment candidate, which contains 3.9%...
View ArticleAviceda's geographic atrophy drug fails mid-stage study. Can it do better in...
Aviceda Therapeutics is pushing forward with Phase 3 plans for its experimental eye drug despite failing a Phase 2b study in geographic atrophy. The mid-stage trial compared Aviceda’s AVD-104 to...
View ArticleGilead posts second Phase 3 win for new HIV-fighting drug regimen
Gilead may soon be bringing a new cocktail of HIV drugs to market. The company said Monday that a combination of two drugs achieved non-inferiority against its approved treatment Biktarvy in ...
View ArticleWith GLP-1 microdoses, Noom targets lower-BMI group outside FDA obesity drug...
The telehealth company Noom plans to target people with a body mass index well below the requirements for FDA-approved obesity shots, using a microdose GLP-1 offering. The strategy is becoming more...
View ArticleFDA speeds up review of J&J's multiple myeloma combo treatment following...
Johnson & Johnson's Tecvayli and Darzalex combination treatment scored another win in second-line multiple myeloma, with the FDA moving with unprecedented speed after the latest data to issue a new...
View ArticleFDA wants to use more real-world data and calls again for early-phase trials...
The FDA will consider more real-world data in drug and device applications, including from large datasets that don't have identifiable patient data, Commissioner Marty Makary told a Wall Street...
View ArticleLenz discloses case of retinal tear in presbyopia eye drop patient
Lenz Therapeutics alarmed investors on Friday when it disclosed a report of a serious complication in a patient who took its commercial eye drop for blurry near vision. The drug, called Vizz, was
View ArticleSanofi licenses ADEL’s tau-targeting Alzheimer’s drug for $80M upfront
In its second deal this week, Sanofi is spending $80 million upfront to license an Alzheimer’s drug candidate developed by the South Korean biotech ADEL. The French drugmaker will get global rights to...
View ArticleFDA extends decision on Aldeyra's dry eye disease drug
The FDA extended its review of Aldeyra Therapeutics' dry eye disease drug reproxalap, after rejecting it twice before, to a new action date of March 16. Aldeyra's stock {$ALDX} was down ...
View ArticleRTW startup signs autoimmune antibody pact with China’s GenSci
RTW Investments is making a licensing deal with a China biotech for an antibody that’s being developed for two related autoimmune conditions called Graves’ disease and thyroid eye disease. As part of...
View ArticleAeovian gets $55M for tuberous sclerosis complex, to explore prospects in...
Aeovian Pharmaceuticals has collected $55 million to see if it can prove its mTORC1 approach in tuberous sclerosis complex and consider getting into obesity with another mechanism. The Series B,...
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